Exemestane Tablet
NDC Package 70771-1374-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Exemestane tablets is a medication used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. This formulation utilizes a tablet delivery system. Marketed by Zydus Lifesciences Limited, this product is identified by NDC 70771-1374 and is authorized under FDA application ANDA202602.

Identification & Billing

NDC Package Code
70771-1374-3
Package Description
30 TABLET in 1 BOTTLE
Product Code
70771-1374
11-Digit Billing Format
70771137403
RxNorm Crosswalk
RxCUI: 310261 - exemestane 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Exemestane
Non-Proprietary Name
Exemestane
Substance Name
Exemestane
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
EXEMESTANE 25 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. Exemestane is also used to help prevent the cancer from returning. Some breast cancers are made to grow faster by a natural hormone called estrogen. Exemestane decreases the amount of estrogen the body makes and helps to slow or reverse the growth of these breast cancers. Exemestane is usually not used in women of childbearing age.

Regulatory & Marketing

Labeler Name
Zydus Lifesciences Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202602
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-08-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70771-1374-3 identifies a specific commercial package of 30 tablet in 1 bottle of Exemestane, a human prescription drug labeled by Zydus Lifesciences Limited. This tablet is formulated for oral use and contains exemestane as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Zydus Lifesciences Limited on October 08, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. Exemestane is also used to help prevent the cancer from returning. Some breast cancers are made to grow faster by a natural hormone called estrogen. Exemestane decreases the amount of estrogen the body makes and helps to slow or reverse the growth of these breast cancers. Exemestane is usually not used in women of childbearing age.

How is this Zydus Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70771137403. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
70771-1374-3
11-Digit CMS (5-4-2)
70771-1374-03

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.